Last reviewed · How we verify

NCT02185794

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection

Completed Phase 1 Results posted Last updated 17 September 2020
What this trial tests

Phase 1 trial testing Voxilaprevir in Hepatitis C Virus Infection in 101 participants. Completed in 28 September 2015.

Timeline
13 June 2014
Primary endpoint
22 December 2014
28 September 2015

Quick facts

Lead sponsorGilead Sciences
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment101
Start date13 June 2014
Primary completion22 December 2014
Estimated completion28 September 2015
Sites11 locations across Puerto Rico, United States

Drugs / interventions tested

Conditions studied

Sponsor

Gilead Sciences — full company profile →

Who can join

Adults 18 to 65, any sex, with Hepatitis C Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Experiencing Treatment Emergent Adverse Events Primary · First dose date up to Day 3 plus 30 days
GroupValue95% CI
Placebo25.0
Voxilaprevir 50 mg14.3
Voxilaprevir 100 mg16.7
Voxilaprevir 300 mg13.3
Voxilaprevir 100 mg Fed33.3
Voxilaprevir 100 mg + SOF/VEL 400/100 mg12.5
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Primary · First dose date up to Day 3 plus 30 days

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.

Grade 1
GroupValue95% CI
Placebo37.5
Voxilaprevir 50 mg28.6
Voxilaprevir 100 mg26.7
Voxilaprevir 300 mg20.0
Voxilaprevir 100 mg Fed50.0
Voxilaprevir 100 mg + SOF/VEL 400/100 mg62.5
Grade 2
GroupValue95% CI
Placebo25.0
Voxilaprevir 50 mg28.6
Voxilaprevir 100 mg33.3
Voxilaprevir 300 mg13.3
Voxilaprevir 100 mg Fed0
Voxilaprevir 100 mg + SOF/VEL 400/100 mg12.5
Grade 3
GroupValue95% CI
Placebo0
Voxilaprevir 50 mg14.3
Voxilaprevir 100 mg10.0
Voxilaprevir 300 mg26.7
Voxilaprevir 100 mg Fed33.3
Voxilaprevir 100 mg + SOF/VEL 400/100 mg0
Grade 4
GroupValue95% CI
Placebo0
Voxilaprevir 50 mg0
Voxilaprevir 100 mg3.3
Voxilaprevir 300 mg0
Voxilaprevir 100 mg Fed0
Voxilaprevir 100 mg + SOF/VEL 400/100 mg0
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA Primary · Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48

The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.

Change at Day 4
GroupValue95% CI
Placebo (GT 1a, Cohort 1)-0.12± 0.136
Voxilaprevir 50 mg (GT 1a, Cohort 1)-3.81± 0.516
Voxilaprevir 100 mg (GT 1a, Cohort 1)-3.97± 0.608
Voxilaprevir 300 mg (GT 1a, Cohort 1)-3.33± 0.902
Placebo (GT 3, Cohort 2)-0.24± 0.813
Voxilaprevir 50 mg (GT 3, Cohort 2)-1.47± 0.416
Voxilaprevir 100 mg (GT 3, Cohort 2)-3.20± 0.364
Voxilaprevir 300 mg (GT 3, Cohort 2)-3.57± 0.483
Placebo (GT 2, Cohort 3)0.00± 0.104
Voxilaprevir 100 mg (GT 2, Cohort 3)-3.41± 0.444
Voxilaprevir 100 mg (GT 4, Cohort 4)-3.50± 0.677
Voxilaprevir 100 mg (GT 1b, Cohort 5)-3.57± 0.227
Change at Day 5
GroupValue95% CI
Placebo (GT 1a, Cohort 1)-0.20± 0.519
Voxilaprevir 50 mg (GT 1a, Cohort 1)-3.58± 1.104
Voxilaprevir 100 mg (GT 1a, Cohort 1)-4.03± 0.594
Voxilaprevir 300 mg (GT 1a, Cohort 1)-3.37± 0.894
Placebo (GT 3, Cohort 2)-0.17± 0.285
Voxilaprevir 50 mg (GT 3, Cohort 2)-1.43± 0.606
Voxilaprevir 100 mg (GT 3, Cohort 2)-3.00± 0.470
Voxilaprevir 300 mg (GT 3, Cohort 2)-3.28± 0.515
Placebo (GT 2, Cohort 3)-0.12± 0.151
Voxilaprevir 100 mg (GT 2, Cohort 3)-3.37± 0.480
Voxilaprevir 100 mg (GT 4, Cohort 4)-3.61± 0.702
Voxilaprevir 100 mg (GT 1b, Cohort 5)-3.60± 0.390
Change at Day 6
GroupValue95% CI
Placebo (GT 1a, Cohort 1)-0.21± 0.479
Voxilaprevir 50 mg (GT 1a, Cohort 1)-3.45± 0.829
Voxilaprevir 100 mg (GT 1a, Cohort 1)-3.78± 0.710
Voxilaprevir 300 mg (GT 1a, Cohort 1)-3.47± 0.763
Placebo (GT 3, Cohort 2)-0.06± 0.051
Voxilaprevir 50 mg (GT 3, Cohort 2)-1.06± 0.632
Voxilaprevir 100 mg (GT 3, Cohort 2)-2.52± 0.739
Voxilaprevir 300 mg (GT 3, Cohort 2)-3.13± 0.736
Placebo (GT 2, Cohort 3)-0.04± 0.139
Voxilaprevir 100 mg (GT 2, Cohort 3)-3.22± 0.689
Voxilaprevir 100 mg (GT 4, Cohort 4)-3.69± 0.879
Voxilaprevir 100 mg (GT 1b, Cohort 5)-3.61± 0.601
Change at Day 7
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0.01± 0.340
Voxilaprevir 50 mg (GT 1a, Cohort 1)-3.15± 0.973
Voxilaprevir 100 mg (GT 1a, Cohort 1)-3.88± 0.729
Voxilaprevir 300 mg (GT 1a, Cohort 1)-3.48± 0.695
Placebo (GT 3, Cohort 2)0.02± 0.089
Voxilaprevir 50 mg (GT 3, Cohort 2)-0.76± 0.352
Voxilaprevir 100 mg (GT 3, Cohort 2)-2.00± 0.378
Voxilaprevir 300 mg (GT 3, Cohort 2)-2.89± 0.763
Placebo (GT 2, Cohort 3)-0.05± 0.058
Voxilaprevir 100 mg (GT 2, Cohort 3)-2.80± 0.494
Voxilaprevir 100 mg (GT 4, Cohort 4)-3.70± 0.877
Voxilaprevir 100 mg (GT 1b, Cohort 5)-3.42± 0.710
Change at Day 8
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0.13± 0.260
Voxilaprevir 50 mg (GT 1a, Cohort 1)-2.92± 1.069
Voxilaprevir 100 mg (GT 1a, Cohort 1)-3.54± 0.663
Voxilaprevir 300 mg (GT 1a, Cohort 1)-3.23± 0.726
Placebo (GT 3, Cohort 2)-0.14± 0.158
Voxilaprevir 50 mg (GT 3, Cohort 2)-0.53± 0.379
Voxilaprevir 100 mg (GT 3, Cohort 2)-1.79± 0.627
Voxilaprevir 300 mg (GT 3, Cohort 2)-2.74± 0.916
Placebo (GT 2, Cohort 3)-0.05± 0.090
Voxilaprevir 100 mg (GT 2, Cohort 3)-2.48± 0.355
Voxilaprevir 100 mg (GT 4, Cohort 4)-3.53± 0.637
Voxilaprevir 100 mg (GT 1b, Cohort 5)-3.27± 0.627
Change at Day 10
GroupValue95% CI
Placebo (GT 1a, Cohort 1)-0.06± 0.091
Voxilaprevir 50 mg (GT 1a, Cohort 1)-2.69± 1.116
Voxilaprevir 100 mg (GT 1a, Cohort 1)-3.33± 0.756
Voxilaprevir 300 mg (GT 1a, Cohort 1)-2.97± 0.918
Placebo (GT 3, Cohort 2)-0.23± 0.180
Voxilaprevir 50 mg (GT 3, Cohort 2)-0.28± 0.330
Voxilaprevir 100 mg (GT 3, Cohort 2)-1.18± 1.055
Voxilaprevir 300 mg (GT 3, Cohort 2)-2.17± 1.394
Placebo (GT 2, Cohort 3)-0.13± 0.022
Voxilaprevir 100 mg (GT 2, Cohort 3)-2.28± 0.469
Voxilaprevir 100 mg (GT 4, Cohort 4)-3.61± 0.674
Voxilaprevir 100 mg (GT 1b, Cohort 5)-3.08± 0.740
Change at Week 48
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0.41± 0.873
Voxilaprevir 50 mg (GT 1a, Cohort 1)0.08± 0.337
Voxilaprevir 100 mg (GT 1a, Cohort 1)-0.80± 2.094
Voxilaprevir 300 mg (GT 1a, Cohort 1)-0.73± 2.352
Placebo (GT 3, Cohort 2)0.41
Voxilaprevir 50 mg (GT 3, Cohort 2)-0.03± 0.221
Voxilaprevir 100 mg (GT 3, Cohort 2)0.54
Voxilaprevir 300 mg (GT 3, Cohort 2)0.06± 0.370
Placebo (GT 2, Cohort 3)-0.02
Voxilaprevir 100 mg (GT 2, Cohort 3)-0.02
Voxilaprevir 100 mg (GT 4, Cohort 4)0.18± 0.247
Voxilaprevir 100 mg (GT 1b, Cohort 5)-0.57± 2.389
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48 Secondary · Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48

The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).

Pre Day 1 Dose
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.73± 0.307
Voxilaprevir 50 mg (GT 1a, Cohort 1)6.30± 0.497
Voxilaprevir 100 mg (GT 1a, Cohort 1)6.35± 0.526
Voxilaprevir 300 mg (GT 1a, Cohort 1)6.05± 0.558
Placebo (GT 3, Cohort 2)6.11± 0.480
Voxilaprevir 50 mg (GT 3, Cohort 2)5.61± 0.612
Voxilaprevir 100 mg (GT 3, Cohort 2)6.75± 0.346
Voxilaprevir 300 mg (GT 3, Cohort 2)6.01± 0.773
Placebo (GT 2, Cohort 3)6.71± 0.059
Voxilaprevir 100 mg (GT 2, Cohort 3)6.24± 0.394
Voxilaprevir 100 mg (GT 4, Cohort 4)6.16± 0.730
Voxilaprevir 100 mg (GT 1b, Cohort 5)6.23± 0.608
Day 4
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.62± 0.378
Voxilaprevir 50 mg (GT 1a, Cohort 1)2.56± 0.705
Voxilaprevir 100 mg (GT 1a, Cohort 1)2.38± 0.759
Voxilaprevir 300 mg (GT 1a, Cohort 1)2.72± 0.943
Placebo (GT 3, Cohort 2)5.87± 0.332
Voxilaprevir 50 mg (GT 3, Cohort 2)4.22± 0.878
Voxilaprevir 100 mg (GT 3, Cohort 2)3.54± 0.455
Voxilaprevir 300 mg (GT 3, Cohort 2)2.44± 0.693
Placebo (GT 2, Cohort 3)6.71± 0.164
Voxilaprevir 100 mg (GT 2, Cohort 3)2.83± 0.611
Voxilaprevir 100 mg (GT 4, Cohort 4)2.65± 0.533
Voxilaprevir 100 mg (GT 1b, Cohort 5)2.67± 0.500
Day 5
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.53± 0.426
Voxilaprevir 50 mg (GT 1a, Cohort 1)2.73± 1.203
Voxilaprevir 100 mg (GT 1a, Cohort 1)2.33± 0.643
Voxilaprevir 300 mg (GT 1a, Cohort 1)2.67± 0.947
Placebo (GT 3, Cohort 2)5.94± 0.195
Voxilaprevir 50 mg (GT 3, Cohort 2)4.19± 1.104
Voxilaprevir 100 mg (GT 3, Cohort 2)3.75± 0.455
Voxilaprevir 300 mg (GT 3, Cohort 2)2.73± 0.780
Placebo (GT 2, Cohort 3)6.59± 0.210
Voxilaprevir 100 mg (GT 2, Cohort 3)2.87± 0.603
Voxilaprevir 100 mg (GT 4, Cohort 4)2.55± 0.549
Voxilaprevir 100 mg (GT 1b, Cohort 5)2.63± 0.764
Day 6
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.52± 0.320
Voxilaprevir 50 mg (GT 1a, Cohort 1)2.85± 1.000
Voxilaprevir 100 mg (GT 1a, Cohort 1)2.57± 1.028
Voxilaprevir 300 mg (GT 1a, Cohort 1)2.57± 0.818
Placebo (GT 3, Cohort 2)6.05± 0.532
Voxilaprevir 50 mg (GT 3, Cohort 2)4.55± 1.203
Voxilaprevir 100 mg (GT 3, Cohort 2)4.23± 0.604
Voxilaprevir 300 mg (GT 3, Cohort 2)2.88± 0.882
Placebo (GT 2, Cohort 3)6.68± 0.199
Voxilaprevir 100 mg (GT 2, Cohort 3)3.02± 0.754
Voxilaprevir 100 mg (GT 4, Cohort 4)2.46± 0.300
Voxilaprevir 100 mg (GT 1b, Cohort 5)2.85± 0.685
Day 7
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.74± 0.059
Voxilaprevir 50 mg (GT 1a, Cohort 1)3.15± 1.268
Voxilaprevir 100 mg (GT 1a, Cohort 1)2.47± 0.821
Voxilaprevir 300 mg (GT 1a, Cohort 1)2.56± 0.714
Placebo (GT 3, Cohort 2)6.13± 0.569
Voxilaprevir 50 mg (GT 3, Cohort 2)4.85± 0.886
Voxilaprevir 100 mg (GT 3, Cohort 2)4.75± 0.268
Voxilaprevir 300 mg (GT 3, Cohort 2)3.12± 0.991
Placebo (GT 2, Cohort 3)6.67± 0.001
Voxilaprevir 100 mg (GT 2, Cohort 3)3.44± 0.613
Voxilaprevir 100 mg (GT 4, Cohort 4)2.45± 0.359
Voxilaprevir 100 mg (GT 1b, Cohort 5)2.82± 1.111
Day 8
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.86± 0.144
Voxilaprevir 50 mg (GT 1a, Cohort 1)3.38± 1.019
Voxilaprevir 100 mg (GT 1a, Cohort 1)2.81± 0.901
Voxilaprevir 300 mg (GT 1a, Cohort 1)2.81± 0.671
Placebo (GT 3, Cohort 2)5.97± 0.323
Voxilaprevir 50 mg (GT 3, Cohort 2)5.08± 0.655
Voxilaprevir 100 mg (GT 3, Cohort 2)4.96± 0.531
Voxilaprevir 300 mg (GT 3, Cohort 2)3.27± 1.100
Placebo (GT 2, Cohort 3)6.66± 0.031
Voxilaprevir 100 mg (GT 2, Cohort 3)3.76± 0.497
Voxilaprevir 100 mg (GT 4, Cohort 4)2.62± 0.278
Voxilaprevir 100 mg (GT 1b, Cohort 5)2.96± 1.111
Day 10
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.68± 0.263
Voxilaprevir 50 mg (GT 1a, Cohort 1)3.61± 1.041
Voxilaprevir 100 mg (GT 1a, Cohort 1)3.03± 0.857
Voxilaprevir 300 mg (GT 1a, Cohort 1)3.07± 0.887
Placebo (GT 3, Cohort 2)5.88± 0.300
Voxilaprevir 50 mg (GT 3, Cohort 2)5.43± 0.803
Voxilaprevir 100 mg (GT 3, Cohort 2)5.56± 0.987
Voxilaprevir 300 mg (GT 3, Cohort 2)3.83± 1.417
Placebo (GT 2, Cohort 3)6.58± 0.081
Voxilaprevir 100 mg (GT 2, Cohort 3)3.96± 0.555
Voxilaprevir 100 mg (GT 4, Cohort 4)2.54± 0.553
Voxilaprevir 100 mg (GT 1b, Cohort 5)3.15± 1.210
Week 48
GroupValue95% CI
Placebo (GT 1a, Cohort 1)6.97± 0.488
Voxilaprevir 50 mg (GT 1a, Cohort 1)6.29± 0.825
Voxilaprevir 100 mg (GT 1a, Cohort 1)5.55± 2.007
Voxilaprevir 300 mg (GT 1a, Cohort 1)5.20± 2.085
Placebo (GT 3, Cohort 2)6.18
Voxilaprevir 50 mg (GT 3, Cohort 2)5.13± 0.207
Voxilaprevir 100 mg (GT 3, Cohort 2)7.29
Voxilaprevir 300 mg (GT 3, Cohort 2)6.38± 1.479
Placebo (GT 2, Cohort 3)6.65
Voxilaprevir 100 mg (GT 2, Cohort 3)6.13
Voxilaprevir 100 mg (GT 4, Cohort 4)6.34± 0.696
Voxilaprevir 100 mg (GT 1b, Cohort 5)5.65± 2.473
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA Secondary · Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48

Categorical declines from baseline were summarized by the number of participants with a \< 1, ≥ 1 to \<2, ≥ 2 to \<3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).

Day 4
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)1
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)1
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)4
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)2
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)4
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)1
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)1
Voxilaprevir 100 mg (GT 4, Cohort 4)1
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Day 5
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)4
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)2
Voxilaprevir 50 mg (GT 3, Cohort 2)1
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)1
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)4
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)1
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)1
Voxilaprevir 100 mg (GT 3, Cohort 2)2
Voxilaprevir 300 mg (GT 3, Cohort 2)2
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 4, Cohort 4)1
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Day 6
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Placebo (GT 1a, Cohort 1)4
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)2
Voxilaprevir 50 mg (GT 3, Cohort 2)2
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)1
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)4
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)3
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 4, Cohort 4)1
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Day 7
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)4
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)2
Voxilaprevir 50 mg (GT 3, Cohort 2)4
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)2
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)2
Voxilaprevir 100 mg (GT 3, Cohort 2)3
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)2
Voxilaprevir 300 mg (GT 3, Cohort 2)2
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)3
Voxilaprevir 100 mg (GT 4, Cohort 4)1
Voxilaprevir 100 mg (GT 1b, Cohort 5)2
Day 8
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)4
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)2
Voxilaprevir 50 mg (GT 3, Cohort 2)6
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)2
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)4
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)2
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)3
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)2
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)6
Voxilaprevir 100 mg (GT 4, Cohort 4)1
Voxilaprevir 100 mg (GT 1b, Cohort 5)2
Day 10
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)1
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)4
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)2
Voxilaprevir 50 mg (GT 3, Cohort 2)5
Voxilaprevir 100 mg (GT 3, Cohort 2)2
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)3
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)2
Voxilaprevir 300 mg (GT 3, Cohort 2)2
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)2
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)2
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)3
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)4
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Week 48
GroupValue95% CI
Placebo (GT 1a, Cohort 1)2
Voxilaprevir 50 mg (GT 1a, Cohort 1)4
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)2
Placebo (GT 3, Cohort 2)1
Voxilaprevir 50 mg (GT 3, Cohort 2)3
Voxilaprevir 100 mg (GT 3, Cohort 2)5
Voxilaprevir 300 mg (GT 3, Cohort 2)5
Placebo (GT 2, Cohort 3)1
Voxilaprevir 100 mg (GT 2, Cohort 3)5
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Placebo (GT 1a, Cohort 1)2
Voxilaprevir 50 mg (GT 1a, Cohort 1)4
Voxilaprevir 100 mg (GT 1a, Cohort 1)6
Voxilaprevir 300 mg (GT 1a, Cohort 1)5
Placebo (GT 3, Cohort 2)1
Voxilaprevir 50 mg (GT 3, Cohort 2)3
Voxilaprevir 100 mg (GT 3, Cohort 2)1
Voxilaprevir 300 mg (GT 3, Cohort 2)2
Placebo (GT 2, Cohort 3)1
Voxilaprevir 100 mg (GT 2, Cohort 3)1
Voxilaprevir 100 mg (GT 4, Cohort 4)4
Voxilaprevir 100 mg (GT 1b, Cohort 5)4
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND) Secondary · Days 4, 5, 6, 7, 8, 10, and Week 48

The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).

Day 4 < LLOQ detected
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Day 5 < LLOQ detected
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)1
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Day 6 < LLOQ TND
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0
Day 7 < LLOQ detected
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Day 8 < LLOQ detected
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Day 10 < LLOQ TND
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)0
Voxilaprevir 300 mg (GT 1a, Cohort 1)0
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)1
Week 48 < LLOQ TND
GroupValue95% CI
Placebo (GT 1a, Cohort 1)0
Voxilaprevir 50 mg (GT 1a, Cohort 1)0
Voxilaprevir 100 mg (GT 1a, Cohort 1)1
Voxilaprevir 300 mg (GT 1a, Cohort 1)1
Placebo (GT 3, Cohort 2)0
Voxilaprevir 50 mg (GT 3, Cohort 2)0
Voxilaprevir 100 mg (GT 3, Cohort 2)0
Voxilaprevir 300 mg (GT 3, Cohort 2)0
Placebo (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 2, Cohort 3)0
Voxilaprevir 100 mg (GT 4, Cohort 4)0
Voxilaprevir 100 mg (GT 1b, Cohort 5)0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 0/8 (0%)
Deaths: 0/8
Voxilaprevir 50 mg
Serious: 0/14 (0%)
Deaths: 0/14
Voxilaprevir 100 mg
Serious: 0/30 (0%)
Deaths: 0/30
Voxilaprevir 300 mg
Serious: 0/15 (0%)
Deaths: 0/15
Voxilaprevir 100 mg Fed
Serious: 1/6 (17%)
Deaths: 0/6
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
Serious: 0/16 (0%)
Deaths: 0/16

Serious adverse events (1 terms)

ReactionSystemPlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/…
Atrial fibrillationCardiac disorders
Other adverse events (8 terms — click to expand)

ReactionSystemPlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/…
DiarrhoeaGastrointestinal disorders
HeadacheNervous system disorders
ConstipationGastrointestinal disorders
ContusionInjury, poisoning and procedural complications
ArthralgiaMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
Dermatitis contactSkin and subcutaneous tissue disorders

Most-reported serious reactions: Atrial fibrillation.

Data from ClinicalTrials.gov NCT02185794 adverse events section.

Sponsor's own description

The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Direct-acting antivirals for chronic hepatitis C.
    Jakobsen JC, Nielsen EE, Feinberg J, Katakam KK, et al · · 2017 · cited 61× · PMID 28922704 · DOI 10.1002/14651858.cd012143.pub3
  2. Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and/or Renal Impairment.
    Smolders EJ, de Kanter CT, van Hoek B, Arends JE, et al · · 2016 · cited 57× · PMID 27098247 · DOI 10.1007/s40264-016-0420-2
  3. Direct-acting antivirals for chronic hepatitis C.
    Jakobsen JC, Nielsen EE, Feinberg J, Katakam KK, et al · · 2017 · cited 37× · PMID 28585310 · DOI 10.1002/14651858.cd012143.pub2
  4. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor.
    Lawitz E, Yang JC, Stamm LM, Taylor JG, et al · · 2018 · cited 23× · PMID 29063860 · DOI 10.3851/imp3202
  5. Sofosbuvir + velpatasvir + voxilaprevir for the treatment of hepatitis C infection.
    Cory TJ, Mu Y, Gong Y, Kodidela S, et al · · 2018 · cited 9× · PMID 29634360 · DOI 10.1080/14656566.2018.1459567

Verify or expand the search:

Other trials of Voxilaprevir

Trials testing the same drug.

Other recruiting trials for Hepatitis C Virus Infection

Currently open trials in the same condition.

Other Gilead Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02185794.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing